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PCB007-Aug2025

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88 PCB007 MAGAZINE I AUGUST 2025 for exclusions of requirements that don't apply to the organization. ISO 9001: 2008—The 2008 revision introduced some new wording and clarifications, but no new requirements. ISO 9001: 2015—The latest revision of the stan- dard introduced the new high-level structure (Annex SL) and featured several new and modified requirements, most notably the concept of risk- based thinking. • ISO published ISO 9001—2015/AMD1: 2024 in February 2024, which amends Section 4 to include climate action considerations. (Anyone who knows me well understands how I feel about this amendment!) The 2015 revision finally got it right with Annex SL, which provided a standard with requirements in an order that actually made sense, and followed the Plan-Do-Check-Act (PDCA) process preached so heavily in the standard itself. The Aerospace version (AS9100D) follows this same Annex SL and includes 100% of the requirements of ISO 9001. Because it is based on ISO 9001, we can probably expect a Revision E of AS9100 in 2027. It is my great hope that the powers that be with oversight into the development of ISO 13485 (medical) and IATF 16949 (automotive) will jump on the Annex SL bandwagon and align with ISO 9001. As most com- panies have multiple "merit badges" (QMS certifi- cations) this would make integration much easier (but perhaps that would make too much sense!). Anticipated Version 6 Changes The upcoming revision of ISO 9001 aims to address several key areas to ensure the standard remains relevant in today's rapidly changing business envi- ronment. Here are some predicted changes along with my personal thoughts: • Enhanced risk management: Improvements in how organizations identify, assess, and manage risks. I would expect this to more closely align with the Aerospace AS9100 requirements and add an extra focus on min- imizing the type of supply chain disruptions that crippled the industry during the COVID pandemic. • Stakeholder: Greater emphasis on engaging with stakeholders to meet their needs and expectations. "Interested Party" feedback is a current requirement, but expect that to be an increased, more formalized focus going forward. T H E R I G H T A P P ROAC H

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